Research Studies/Clinical Trials

Control samples for the Effect of PKU on the Gut Microbiome
October 11, 2019

We are conducting a research study to determine if and how certain groups of bacteria naturally present in the gastrointestinal tracts of PKU patients are influenced by adherence to the recommended PKU diet.

You or your children are invited to participate in this research as a healthy non-PKU control. Participation in the study requires submission of a stool sample and completion of a dietary survey. The stool sample may be collected at any time (at home or at work) with a collection kit we will provide, and returned to our laboratory at your convenience. The survey will take no more than 20-30 minutes. Sample collection should take no more than 10 minutes. The entire study, including consent forms, should take no more than 1 hour to complete.

IF YOU HAVE A FOOD LOG FOR YOU/YOUR CHILD FOR 1 WEEK PRIOR TO SAMPLE COLLECTION THAT IS VERY HELPFUL. Just noting what you had to eat, and the approximate quantity is very helpful. A food log is NOT mandatory to participate; it simply gives us more information.

Ages 0-50 years old
No antibiotics in the last 6 months
Eat a healthy diet (good amount of fruits, veggies, and whole grains, few processed foods)
No known digestive system issues
Not pregnant

To participate, please email Viviana Mancilla at

If you have any questions regarding this research project, please feel free to contact:
• Principal Investigator: Dr. Michael Allen at (817) 735-5038 or by email at
If you have any questions about your rights as a research subject, please contact the North Texas Regional IRB at (817) 735-0409. Thank you for your interest in this study.